MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	S-65-040-120-P6
Medical Device Problem Codes	Activation Failure (3270); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported activation/deployment failure appears to be related to circumstances of the procedure as it is likely that the during stent deployment the introducer sheath was too close to the proximal end of the stent; thus resulting in the stent to partially deploy into the introducer sheath.As reported, when the sheath was pulled the stent moved into the common femoral/external iliac artery and remains there; thus resulting in the reported migration.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat the 6.5 mm proximal superficial femoral artery with no calcification or tortuosity.The vessel was prepared with a 7x40 mm balloon.Atherectomy was not used.The 6.5x40 mm supera self expanding stent (ses) partially (about 5 mm) deployed in the sheath.When the sheath was pulled, the stent moved into the common femoral/external iliac artery and remains there.This is an unintended location.The target lesion was not treated.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16448579
• Report Number: 2024168-2023-01996
• Device Sequence Number: 20298551
• Product Code: NIP
• UDI-Device Identifier: 08717648226229
• UDI-Public: 08717648226229
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: S-65-040-120-P6
• Device Catalogue Number: S-65-040-120-P6
• Device Lot Number: 2111161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .014 GUIDE WIRE; 6FR 45 CM SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown